Federal regulators are asking Novavax to complete an additional randomized clinical trial on its Covid-19 vaccine after previously delaying approval, people familiar with the matter said, a request that could be so prohibitively expensive the company might not be able to fulfill it.

Novavax has been available since 2022 through a pandemic-era Emergency Use Authorization. A decision on full approval – which rival mRNA shots from Moderna and Pfizer and its partner BioNTech already have - was due from the Food and Drug Administration by April 1, but had been delayed by the FDA without explanation.

(Reuters) -Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after previously delaying approval, the Wall Street Journal reported on Friday, citing people familiar with the matter.